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510(k) K252090

Pterygoid Indication for GM Helix Implants by JJGC Indústria e Comércio de Materiais Dentários S.A. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2025
Date Received
July 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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